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Proven efficacy in a foam vehicle.1
That’s Finacea® Foam.
Reduction in inflammatory lesion count
PRIMARY ENDPOINT: Mean nominal changes in inflammatory lesion count from baseline to end of 12-week treatment period1-3
Significant reduction in the mean number of inflammatory lesions with Finacea® Foam vs foam vehicle* at 12 weeks.4
*Foam vehicle contained the same exact hydrophilic foam minus azelaic acid.1
†End of trial.
‡P-value is calculated from 2-sided t test.
IGA* success rates
PRIMARY ENDPOINT: IGA success rate from baseline to end of 12-week treatment period1-3
Clinical results: Superior success rates with Finacea® Foam vs foam vehicle¶1
*Investigator's Global Assessment.
†P-value is calculated from the Pearson χ2 test.
‡End of trial.
¶Foam vehicle contained the same exact hydrophilic foam minus azelaic acid.1
Two pivotal, multicenter, randomized, double-blind, vehicle-controlled, 12-week clinical trials involving a total of 1,362 patients (active N=681; vehicle N=681)
Finacea® Foam was compared to its foam vehicle* without azelaic acid
Subjects' ages ranged from 19 to 92 years (mean age 50.6 years). 95.7% of subjects participating in the trials were Caucasian and 73.4% were female
Enrolled patients had papulopustular rosacea with a mean lesion count of 21.3 (range 12 to 50) inflammatory papules and pustules
Those with ocular rosacea, phymatous rosacea, or plaque-type rosacea lesions
Those with rosacea that requires systemic treatment
Those who are known nonresponders to azelaic acid
Those with a known hypersensitivity to any ingredients of the study drug
Finacea® Foam or the foam vehicle were to be applied twice daily for 12 weeks; no other topical or systemic medication affecting the course of rosacea and/or evaluability was to be used during the studies
The efficacy endpoints in the 2 clinical trials were:
Nominal change in inflammatory lesion count from baseline, AND success defined as a score of "Clear" or "Minimal" with at least a 2-step reduction from baseline on a 5-point IGA.
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IGA (criteria used to define success)1
Numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate to severe erythema
Pronounced number of papules and or pustules, but less than numerous papules and or pustules; moderate erythema
Few papules and/or pustules; mild erythema
Rare papules and/or pustules; faint, up to but not including mild erythema
No papules and/or pustules; no erythema
Graphic representation is for illustrative purposes only.
Success is defined as at least a 2-step reduction
Success is defined as a score of "Clear" or "Minimal" with at least a 2-step reduction, "Moderate" to "Minimal" from baseline, or "Mild" to "Clear" from baseline on a 5-point IGA.1
Adverse reactions with Finacea® Foam versus foam vehicle
Adverse reactions occurring in ≥0.5% of subjects in both
*Foam vehicle contained the same exact hydrophilic foam minus azelaic acid.
†Application site pain is a term used to describe disagreeable skin sensations, including burning, stinging, paraesthesia, and tenderness.
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Finacea® Foam [prescribing information]. LEO Pharma Inc.
Draelos ZD, Elewski BE, Harper JC, et al. A randomized, phase 3, double-blind, vehicle-controlled clinical trial to evaluate the safety and efficacy of 12 weeks of twice-daily azelaic acid foam, 15% in papulopustular rosacea. Poster presented at: 35th Anniversary Fall Clinical Dermatology Conference; Las Vegas, Nevada; October 20-23, 2016.
Draelos ZD, Elewski B, Staedler G, et al. Azelaic acid foam 15% in the treatment of papulopustular rosacea. A randomized, double-blind, vehicle controlled study. Cutis. 2013;92(1):306-317.
Finacea® (azelaic acid) Foam, 15% is indicated for the topical treatment of inflammatory papules and pustules of mild to moderate rosacea.
IMPORTANT SAFETY INFORMATION
For topical use only. Finacea Foam is not for oral, ophthalmic or intravaginal use.
Before applying Finacea Foam, cleanse affected area(s) using only very mild soaps or soapless cleansing lotion and pat dry with a soft towel.
Apply a thin layer of Finacea Foam twice daily (morning and evening) to the entire facial area (cheeks, chin, forehead, and nose). Wash hands immediately after application.
Avoid the use of occlusive dressings or wrappings at the application site. Avoid use of alcoholic cleansers, tinctures and astringents, abrasives and peeling agents.
Patients should be reassessed if no improvement is observed upon completing 12 weeks of therapy.
Warnings and Precautions
Hypopigmentation: There have been isolated reports of hypopigmentation after use of azelaic acid. Because azelaic acid has not been well studied in patients with dark complexion, monitor these patients for early signs of hypopigmentation.
Eye and Mucous Membrane Irritation: Azelaic acid has been reported to cause irritation of the eyes. Avoid contact with the eyes, mouth and other mucous membranes. If Finacea Foam does come in contact with the eyes, wash the eyes with large amounts of water and consult a healthcare professional if eye irritation persists.
Flammability: The propellant in Finacea Foam is flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application. Do not puncture and/or incinerate the containers. Do not expose containers to heat and/or store at temperatures above 120°F (49°C).
In clinical studies, the most frequently observed adverse reactions reported in ≥0.5% of subjects treated with Finacea Foam included local site pain (6.2%), pruritus (2.5%), dryness (0.7%), and erythema (0.7%).
USE IN SPECIFIC POPULATIONS
Pregnancy: Azelaic acid is minimally absorbed systemically following topical route of administration, and maternal use is not expected to result in fetal exposure to the drug.
Lactation: Azelaic acid is naturally present in human milk. When used as prescribed, azelaic acid is unlikely to be absorbed through the skin in clinically relevant amounts to cause a change in azelaic acid concentration in milk or milk production; therefore, breastfeeding is not expected to result in exposure of the infant to Finacea Foam.
Pediatric Use: The safety and efficacy of Finacea Foam have not been established in pediatric patients.
You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088 (1-800-332-1088).